SAPIEN 3: Newest-generation TAVR system superior to surgery at 1 year

CHICAGO — Researchers reported that transcatheter aortic valve replacement with the newest-generation balloon-expandable system was superior to surgery at 1 year in intermediate-risk patients.

TAVR with the Sapien 3 device (Edwards Lifesciences) at 1 year bested surgical AVR for the primary endpoint of all-cause mortality, stroke, and moderate or severe aortic valve regurgitation, Vinod H. Thourani, MD, said at the American College of Cardiology Scientific Session. The findings were simultaneously published in The Lancet.

Vinod H. Thourani

Thourani, professor of surgery at the Emory University School of Medicine, co-director of the Structural Heart and Valve Center at the Emory Heart and Vascular Center, and chief of cardiothoracic surgery at Emory University Hospital Midtown, Atlanta, and colleagues conducted the SAPIEN 3 observational study in 1,077 patients (mean age, 82 years; 62% men) with severe aortic stenosis at intermediate risk for surgery.

The patients who underwent TAVR with the Sapien 3 device were compared with those who underwent surgical AVR in the PARTNER 2A trial (n = 944; mean age, 82 years; 55% men). The researchers conducted a propensity-score analysis including 963 patients who underwent TAVR and 747 who underwent surgery.

Thirty-day outcomes of the study were reported at the 2015 ACC Scientific Session.

At 1 year, Thourani said, 7.4% of those who had TAVR died, 2.3% had a disabling stroke, 0.6% had reintervention related to the aortic valve and 2% had moderate or severe paravalvular regurgitation. The surgical population at 1 year had 13% mortality, 5.9% disabling stroke and 0.5% aortic valve reintervention. However, the researchers reported, surgery was superior to TAVR in moderate or severe paravalvular regurgitation (weighted difference of proportions, 1.2%; 95% CI, 0.2-2.2; P = .0149).

For the primary endpoint, compared with surgery, TAVR was noninferior (pooled weighted proportion difference, –9.2%; 95% CI, –12.4 to –6; P for noninferiority < .0001) and superior (pooled weighted proportion difference, –9.2%; 95% CI, –13 to –5.4; P for superiority < .0001), according to the researchers.

“The conclusions from the PARTNER 2A randomized trial and this propensity score analysis provide strong evidence that in intermediate-risk patients with severe aortic stenosis, Sapien 3 TAVR therapy compared with surgery improves clinical outcomes and is the preferred therapy,” Thourani said in a presentation. – by Erik Swain

Reference:

Thourani VH, et al. Joint ACC/TCT Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Thourani VH, et al. Lancet. 2016;doi:10.1016/S0140-6736(16)30073-3.

Disclosure: The present analysis required no funding but the SAPIEN 3 and PARTNER 2A studies were funded by Edwards Lifesciences. Thourani reports serving on the steering committee for the PARTNER trial and consulting for Direct Flow Medical, Edwards Lifesciences, Sorin and St. Jude Medical. Please see the full study for a list of the other researchers’ relevant financial disclosures.